Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061946) titled 'Study of Peroneal Muscle Function and Compensatory Movements in Individuals with Chronic Ankle Instability' on June 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - Lateral Ankle Sprain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to clarify the morphological differences in the peroneal muscle group (peroneus longus and peroneus brevis) in subjects including those with chronic ankle instability (CAI), and to evaluate muscle activity during maximal voluntary contraction and torque-maintenance tasks under controlled conditions using a dynamometer.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Muscle morphology of the lower leg muscles is assessed using ultrasound imaging. Surface electromyography is used to record muscle activity during strength measurements.
Interventions/Control_2 - Isometric ankle eversion tasks, including maximal voluntary contraction and torque maintenance tasks, are performed using a dynamometer to assess torque and muscle activity of the lower leg muscles.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - CAI Group (Chronic Ankle Instability)
1. A history of at least 1 ankle sprain.
2. Presence of "giving way", recurrent ankle sprains, or a subjective sense of instability, or meeting the cutoff scores of recommended questionnaires:
CAIT = 5 "yes" responses including a history of ankle sprain
IdFAI >= 11
Coper Group
1. A history of at least 1 ankle sprain.
2. No recurrent ankle sprain for at least 1 year since the initial sprain.
3. CAIT >= 28 and/or IdFAI = 28 and/or IdFAI <= 10.
Key exclusion criteria - 1.Individuals with a history of fracture or surgery involving the foot or ankle.
2.Individuals presenting with lower limb injury, pain, or neurological disorders at the time of consent.
Target Size - 240
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 17 Day
Anticipated trial start date - 2026 Year 06 Month 30 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070879
Disclaimer: Curated by HT Syndication.